Monday, Feb 11 2013
• 10 a.m. (ET)

Safety Concerns At Compounding Pharmacies

A deadly meningitis outbreak last year drew attention to a relatively new segment of the drug industry: large-scale compounding pharmacies. The Food and Drug Administration is calling for new, stronger and clearer legislation to effectively oversee firms that mix custom drugs for specific patients. In the past two decades, compounding pharmacies have grown into a multimillion dollar business, making some of the highest risk drugs available. But they are not required to follow the safety rules that apply to commercial drug makers. State pharmacy boards have an uneven record of policing them. A panel joins Diane to discuss efforts to improve the safety and oversight of compounded drugs.

Guests

Carmen Catizone
executive director, National Association of Boards of Pharmacy.

Kasey Thompson
vice president of policy, planning and communications for the American Society of Health-System Pharmacists.

Lena Sun
reporter, The Washington Post.

David Miller
executive vice president, International Academy of Compounding Pharmacists.

Transcript

10:06:56

MS. DIANE REHMThanks for joining us. I'm Diane Rehm. Safety failures at the New England Compounding Center were linked to 45 deaths and more than 650 illnesses last year. But recent reports show problems at compounding pharmacies have been more widespread than previously thought.

10:07:17

MS. DIANE REHMJoining me to examine regulation of this rapidly growing industry: Washington Post reporter Lena Sun and Kasey Thompson of the American Society of Health-System Pharmacists, joining us by phone from Chicago, Carmen Catizone of the National Association of Boards of Pharmacy, and from Pennsylvania, David Miller of the International Academy of Compounding Pharmacists. Feel free to join us by phone. Call us on 800-433-8850. Send us an email to drshow@wamu.org. Follow us on Facebook or Twitter. Good morning to all of you.

10:08:10

MS. LENA SUNGood morning.

10:08:11

MR. CARMEN CATIZONEGood morning, Diane.

10:08:12

MR. KASEY THOMPSONGood morning, Diane.

10:08:12

SUNGood morning.

10:08:13

REHMGood to have you all with me. Lena Sun, there were congressional hearings after this story broke. Tell me what happened.

10:08:27

SUNThere were two hearings. There was one at the House and one at the Senate. And on the House side, the FDA chief, Peggy Hamburg, was grilled quite thoroughly, I would say, and there was the sense that congressmen were very frustrated that the FDA had known about problems with the NECC but had not acted. On the Senate side, there was more of a sense that the Senate wanted to find a way to give the FDA more authority to control this growing industry.

10:09:06

REHMAnd you said that Congress gave the FDA head a real grilling. What was her response?

10:09:18

SUNHer response was what the FDA's response has been for, basically, since this crisis broke which is that the FDA is hamstrung in what it can do. There are gaps in the law. There are conflicting court decisions. And the practical effect of that is that according to the FDA, in some parts of the country, they can enforce with greater ease. In some parts of the country, they cannot.

10:09:47

SUNAnd because the FDA is not the primary regulator of pharmacies -- it's the state boards of pharmacy that are -- there is this inherent tension about who is supposed to be in charge. And it used to be that pharmacies were more mom-and-pop, mortar and pestle kind of operations. Now that they've grown into these large companies that sell tens of thousands of drugs across state lines to hospitals and clinics, they operate more like manufacturers, and many people believe that they should be regulated as such.

10:10:20

REHMLena Sun, she is a reporter for The Washington Post. Turning to you, Kasey Thompson, you're group represents pharmacists in health care institutions. How does a compounding pharmacy differ from any other pharmacy that represents or has its drugs going into hospitals?

10:10:49

THOMPSONWell, in the hospital setting, the majority of drugs that we use are FDA-approved drugs. Compounding does happen in hospitals from FDA-improved products. Sometimes those products are purchased in some cases from a compounding pharmacy to help make up for certain dosage forms that aren't available from the manufacturer.

10:11:10

THOMPSONThe vast majority of drug products out there are made by an FDA-approved drug manufacturer and are not compounded. However, there's a lot of circumstances, such as in pediatric patients and others, where a dosage form just simply does not exist or an additive exists that a patient has an allergy to in which a compounded drug is necessary.

10:11:31

REHMSo you're saying that compounded drugs do come in to hospitals, and those compounded drugs may not be approved by the FDA.

10:11:45

THOMPSONYes. Well, by nature of them being compounded, they are not approved in that dosage form that they're compounded in. So that is correct. That's not necessarily a bad thing, though. I mean, compounded drugs can be prepared safely for patients and can be used by patients, and they shouldn't be concerned about that. You know, the case of the New England Compounding Center is a very egregious example of or something very bad and illegal happened within our system.

10:12:08

REHMKasey Thompson is vice president of the American Society of Health-System Pharmacists. Turning to you, Carmen Catizone, how much coordination is there actually between the state boards and the FDA as far as oversight of these compounded drugs?

10:12:37

CATIZONEWell, thank you for including us. Prior to this tragedy, the communication and cooperation was probably spotty at best because of the quagmire that you heard about that was the previous person talk about, the question of where the regulation lie. Since that incident, the cooperation and coordination between the FDA and the states has improved tremendously. We have daily contact with them, and the states are working very closely with each other and with the FDA to try and resolve this tragedy.

10:13:08

REHMWell, do you think that going forward, people who learn that drugs coming from a compound at pharmacy can indeed be trusting of that?

10:13:23

CATIZONEI believe going forward, working with the FDA, if we can create this third category and regulate that category, just developed over time, then people can be safe. But there's another component that people have to bring into the equation, and that's when physicians or other health care providers compound their products outside of these pharmacies. Those entities and those individuals have to be regulated the same way and follow the same regulations, or we've created another loophole.

10:13:51

REHMCarmen Catizone, he is executive director of the National Association of Boards of Pharmacy. And turning to you, David Miller, of the International Academy of Compounding Pharmacists, tell me how you began with the spread of these compounded drugs. Rather than going through the FDA, why did that happen?

10:14:26

MR. DAVID MILLERWell, there's two reasons, Diane. First and foremost, as Kasey's from ASHP was explaining, we have patients all over that need medications that can't be met by the currently manufactured products, folks that are sensitive to certain ingredients. So the tradition of compounding or creating a prescription drug by your pharmacist in consultation with your physician is one that's been done for hundreds of years.

10:14:52

MR. DAVID MILLERWhat we've seen and which, I think, was very well pointed out not only in testimony in front of the House and the Senate but also in the excellent article in The Post just last week is that somewhere along the line, some pharmacists have evolved into what are essentially pharmaceutical manufacturers.

10:15:11

MR. DAVID MILLERAnd we believe, as an organization, that it is very important that we differentiate the role of your local pharmacist who is taking care of an individual patient or supplying medications for a local physician's office or surgical center from these companies that have really gone from starting as a pharmacy but have become drug companies essentially. And we believe that we need to be working not only with our boards of pharmacy but the FDA to address this essentially new and relatively small number of entities that are involved in manufacturing but aren't regulated as manufacturers.

10:15:52

REHMLena Sun, small number?

10:15:56

SUNWell, David, I'm glad to hear from you. I think that most folks would have a hard time understanding how many there are out there. We had a very difficult time trying to define who was in the space. We talked to experts and got the impression there were 15 of these companies. Just the ones we wrote about, CAPS, for example, Central Admixture Pharmacy Services, has annual sales of $500 million. And PharMEDium had sales of over $100 million annual sales. These are maybe a small number, but they dominate the industry.

10:16:36

MILLERAbsolutely. And -- but what's important to also remember is that 15, most of which had been previously identified to the FDA as well as state boards of pharmacy because of problems, do not, however, in any way represent the more than 30,000 pharmacies that are actively providing compounded medications to individual patients on a daily basis. The universe of compounding is actually quite large because each pharmacist is trained in basic compounding.

10:17:08

MILLERIt's something that occurs not only at a local drug store, at your local community hospital as they're preparing medications for folks on the floor but also in small, customized pharmacies that specialize in compounding. These entities, these 15 to 20 that all of us have been trying to identify and grapple with from a regulatory standpoint, have really operated in, if you will, a gray zone, that unusual place between the regulation of a state -- at the state authority and the FDA's authority.

10:17:39

REHMYes. All right. And that's where I want to go. Lena, how much variation is there between individual states and their ability to regulate?

10:17:55

SUNThere is a huge variation, and I think Carmen probably would be able to speak to this better because his group represents the state boards. But in our experience from our reporting, it's all over the board. California is more strict. But in our reporting, we discovered that many state boards have no idea who the compounding pharmacies are who do these large amounts in their states because many of the state laws only differentiate between are you an in-state pharmacy or are you out of state.

10:18:26

REHMLena Sun, a reporter for The Washington Post. We'll take a short break here. When we come back, we'll talk further and take your calls.

10:20:05

REHMAnd welcome back. We're talking about compounding pharmacies, the deadly meningitis outbreak that took place last year, the deaths of 45 people and more than 650 reported illnesses. Carmen Catizone, I want to go back to that very issue and ask what steps your organization and individual states had done to address the kinds of problems that were raised by that meningitis outbreak.

10:20:46

CATIZONESure. As Lena noted, there's a big disparity among the states in terms of the resources and expertise to regulate compounding and particularly to regulate these large-scale manufacturers. What the states are doing is they're employing more resources to get out there and inspect those pharmacies. When they find those pharmacies, then they're bringing in experts that know what sterile compounding should be and what requirements should be in place.

10:21:10

CATIZONEAnd they're utilizing those experts like they haven't utilized them in the past. And finally, they're also employing end-product testing to make sure the products that these pharmacies are compounding are actually safe and free from contaminant.

10:21:22

REHMOK. Let me follow up there. How many experts are you talking about who may go in to inspect or test or even try out?

10:21:36

CATIZONEIn all the states where they feel their expertise is lacking, they'll bringing in these experts from either the colleges or the universities within that state or some of the other national experts, like critical IQ that we're using as part of our inspections (unintelligible).

10:21:47

REHMYou know, it's interesting because the FDA itself has very few resources. So one wonders with state budgets being cut back, how many resources can be brought to bear? Kasey Thompson.

10:22:05

THOMPSONYeah. Resources, Diane, are a huge issue, and you mentioned that from that state's perspective. The state Boards of Pharmacy, in most states, are highly underfunded and, you know, limit the capacity to really sufficiently fulfill the public health mandate that they need to fulfill. And this is a new area that they're going to have to ramp up those resources.

10:22:22

THOMPSONCertainly on the FDA side, you know, we're talking about an agency that regulates 25 cents of every dollar of gross domestic product. And it's a highly under resourced agency. And although our organization supports new legislation to give the FDA additional authority to regulate compounding pharmacies, our biggest concern is that this will be another unfunded mandate from Congress to the FDA. So it's a big issue.

10:22:45

REHMDavid Miller, a question for you from Ed. Let's see where he is. I can't quite tell you. He says, "The FDA recently issued guidance on 'the special risks of compounding.' What is your view of this guidance?"

10:23:08

MILLERWell, Diane, I think the FDA's guidance is consistent with what the agency's position has always been that when a physician selects a medication for a patient, the first choice needs to be a product that has gone through the FDA drug approval process. But we also know that physicians recognize that individual patients don't always have the same needs that can be handled by a manufactured drug and in collaboration with a pharmacist can develop a dosage or a medication that best suits those needs.

10:23:43

MILLERSo in all honesty, the agency's position is one that our organization has always felt was appropriate and which truly defines what compounding is, collaboration of physicians and pharmacists to meet individual patient needs.

10:23:57

REHMWell, let me ask you whether there are actually different standards for compounders that produce sterile versus nonsterile drugs and whether there should be. David Miller.

10:24:15

MILLERYes, Diane. There are some very significant standards that are in our industry published by the United States Pharmacopeia. We call those USP 795 and 797. One of the positions that our organization has taken is that every state in the country needs to mandate than any pharmacist that is engaged in compounding of medications must adhere to those standards legally. Currently, only 17 of our 50 states require that in law. And we feel that as a standard for practice, it also has to be a legal consideration and available for enforcement action by our state Boards of Pharmacy.

10:24:59

REHMBut speaking about those state Boards of Pharmacy, if a compounding pharmacy makes a routine formulation that ships and crosses state lines, can you address or give us a reason as to why they should not be regulated by the FDA?

10:25:28

MILLERWell, I think it depends again on what it is the nature of the relationship between the prescriber, the doctor, and the pharmacy. In the Mid-Atlantic here, we have a number of states that are very close together. Not unusual to have to have a doctor in Maryland who also has a practice just over the border in the District of Columbia or in Virginia. So one of the things we have to look at is, what is that relationship?

10:25:54

MILLERWhere are these folks located, and is this a provision of a prescription drug to the physician or the physician's patients for a medical need? That's markedly different from this evolving industry, if you will, where companies are manufacturing drugs without FDA registration or oversight, employing sales folks and marketing that they can sell their products as opposed to fulfilling prescription orders.

10:26:27

MILLERAnd it is again something that our profession, our regulatory boards at the state level and certainly the FDA and Congress are all grappling with, how do we now take this group, this industry that has grown up and appropriately and adequately regulate them but not in any way hinder individual pharmacies and pharmacists and physicians from taking care of patients?

10:26:53

REHMLena, I gather there have been a number of lawsuits related to these compounders. How have they clarified or even muddied the waters?

10:27:06

SUNThey have muddied the waters, and it makes it very difficult for somebody to say, you know, who has the authority? Do you have the authority, or does this other body have the authority? I wanted to go back to something you had pointed put earlier about the differences. The quality control doesn't matter whether you're a large or a small compounding pharmacy. You are not held to the same kind of safety rules as a drug manufacturer.

10:27:34

SUNFor example, a compounding pharmacy does not have to test every batch of product they make. A drug manufacturer does. A compounding pharmacy does not have to keep samples of every drug they make. A drug manufacturer does. So that means if you have a problem later on with your medication, you can trace back and test to see was there fungus or bacteria. But if you don't have samples, it's very hard to trace outbreaks. And if you don't test as you go, you see how it raises an issue where somebody could get something that was too strong or too weak.

10:28:09

REHMWhat do you mean test as you go?

10:28:13

SUNTesting a batch for potency or sterility that...

10:28:16

REHMAnd you're saying that's not happening.

10:28:18

SUNThat's not required of them. So this...

10:28:21

REHMI don't understand why.

10:28:24

SUNMaybe David Miller would be able to explain better.

10:28:26

REHMWhy should the compounders be free of testing regulations, David? Oh, dear. Have we lost David? David, are you there? All right. We'll have to get him back. Carmen, I wonder if you can answer that question. Why should compounding pharmacies be free of testing and of holding on to samples? I can't hear him.

10:29:09

CATIZONEHello?

10:29:09

REHMYes. Are you there?

10:29:11

CATIZONEI'm here. Can you hear me?

10:29:12

REHMNow, is that David Miller?

10:29:15

CATIZONEHello?

10:29:16

REHMHello. Oh, goodness.

10:29:19

CATIZONEHello?

10:29:20

REHMHello? We're having such problems.

10:29:23

CATIZONEHello?

10:29:24

REHMOK. Is that David Miller?

10:29:27

MILLERYes, ma'am.

10:29:27

REHMOK. Go right ahead, sir.

10:29:29

MILLERWhat was your question, Diane? I'm sorry.

10:29:31

REHMMy question was, why should compounders be free of both testing before those drugs are sent out or holding on to samples so that an individual who may have had difficulties can then check out the original batch?

10:29:53

MILLEROh. Absolutely. And that's a great question. In fact, the USP standards I was referencing before do have mandatory guidelines for when you test a certain size of batch. It's really important that we understand there is a significant difference between a pharmacy-compounded batch and a manufacturer batch. When a pharmacy is compounding a batch of medications, it might be five, 10, 15 doses as compared to what we see from big drug companies in the five to 10 to 15,000 doses at a time.

10:30:31

MILLERSo testing of very small batches becomes, number one, quite complicated in terms of setting those amounts aside and quite expensive as well. And that's why it's important, again, to remember we are and do need to differentiate between the risk that is in the system from a small compounder taking care of a specific patient versus this new model that appears to have evolved from companies like CAPS and PharMEDium where they are literally selling millions of doses in millions of dollars around the country.

10:31:09

REHMWell, but the question I have as a potential patient, suppose I take a drug, how do I know, number one, it's from a compounding pharmacy as opposed to a pharmaceutical manufacturer? And number two, if I have a problem with it, where do I go from there, Lena?

10:31:35

SUNWell, that's exactly the point. The other thing that differentiates compounding pharmacies from drug manufacturers is this. Drug manufacturers are required to report all adverse events. Compounding pharmacies are not.

10:31:49

REHMWhy?

10:31:50

SUNThey're -- because they're not -- they don't come under the FDA regulatory...

10:31:55

REHMThis makes no sense to me.

10:31:57

SUNAnd the other thing is compounded drugs, they're not labeled as such. So if you go to the hospital and you're having an operation for, let's say, open heart surgery, and you're getting cardioplegia solution, which we wrote about in our story, that bag of solution doesn't say that it's coming from a compounded pharmacy.

10:32:21

REHMKasey Thompson, how can this be?

10:32:24

THOMPSONYeah. It's been a real challenge, you know, and you might be aware that in 1997, Congress passed laws that gave FDA authority to oversee compounding pharmacy sort of in the way that we're discussing here.

10:32:35

REHM1987.

10:32:37

THOMPSON1997. I'm sorry if I said 1987.

10:32:38

REHM1997.

10:32:39

THOMPSONYeah, 1997. Those laws were challenged in various courts...

10:32:43

REHMBy?

10:32:44

THOMPSONWell, they were challenged in the 9th Circuit Court 'cause there was provision in the law related to advertising. So there was a freedom of speech issue there. That, in turn, struck down the entire law in that circuit. It was looked at in another circuit and found non-constitutional across the board, and then it's questionable in another based on the Supreme Court's opinion. So there's really spotty regulations in this area that need to be looked at seriously by Congress.

10:33:09

REHMKasey Thompson of the American Society of Health-System Pharmacists, and you're listening to "The Diane Rehm Show." David Miller, I don't certainly don't mean to pick on you, but it does seem to me that there are lots of questions that individuals may have and that there may need to be more widespread FDA oversight of these compounding pharmacies. I'm afraid we keep dropping off with one of our callers. Is he there?

10:34:01

CATIZONEThis is Carmen. Can you hear me?

10:34:02

REHMYes, I can hear you, Carmen.

10:34:03

CATIZONESure. If I can weigh in on this one, the way we see it is it's very clean. The definition of compounding is that it's patient-specific, and if that...

10:34:13

REHMYeah, but it's not that any longer. It has become far more widespread than simply patient-specific.

10:34:23

CATIZONEBut as people have said, that now is manufacturing, and that should fall under the FDA's jurisdiction. It's not a state regulatory issue. It's an FDA issue. It's manufacturing. Once you lose that patient specificity, it's manufacturing. Interstate shipment, the volume changes the perspective from what is needed to further regulate that. So if they're doing high-volume sterile products, there has to be the requirement for a compounding pharmacy as a manufacturer to test those products and keep those tests. There's no way around it.

10:34:51

REHMKasey, is that what's happening?

10:34:54

THOMPSONThat's what's being looked at right now, Diane. You know, Congress is looking at expanding FDA authorities. We believe that the authority for the FDA needs to apply when sterile compounding is happening, when it's happening not in response to a prescription, but for anticipation of use, being shipped in high volumes across state lines. We believe that the FDA's jurisdiction is in that area, and we also don't believe that current law is clear about that, and we think that needs to happen.

10:35:21

REHMWhat can the FDA do to strengthen its own jurisdiction without legislation?

10:35:29

THOMPSONWell, right now, the only thing the FDA is working under is a compliance guide, and it's just that. It's a guideline. So in light of the Food, Drug and Modernization Act, section 503A, in 1997 that's been challenged in the courts, it really does appear that the FDA hasn't been able to do much beyond issue a guidance document.

10:35:49

REHMWhat's the role of physicians, Lena?

10:35:53

SUNPhysicians, I think, have in some way fueled the growth of this industry because they're responding to patients who want individualized, personalized medicine, and also I think there is a cost issue. If you run a pain clinic and you get a steroid injection and you order it from a compounded pharmacy, it is cheaper than if you get it from a drug manufacturer. And if you are getting paid in a lump sum and your drug cost is cheaper, then you get to pocket the difference.

10:36:28

REHMSo, in your view, physicians are doing better by not disclosing that that drug may be coming from a compounding pharmacy.

10:36:44

SUNI'm not sure you would say it -- put it that way. I think that there might -- if their patient has allergies or they want something that's preservative-free -- a lot of drug manufacturers don't make preservative-free steroid injections, for example, and compounders do -- then you take that risk of following what the patient wants. But then you also, you know, depending on who supplies that steroid injection, like NECC did, you will wonder how safe it is.

10:37:15

REHMLast quick question before our break, do physicians have a responsibility to disclose that that prescribed drug is coming from a compounding pharmacy?

10:37:30

SUNI think that if I were the patient, I certainly would want to know.

10:37:33

REHMLena Sun, a reporter for The Washington Post. Short break. I hope our phones are working. We'll be right back.

10:40:04

REHMAnd welcome back. Now, it's time to open the phones, 800-433-8850. First to Cincinnati, Ohio. Good morning, Stephanie.

10:40:18

STEPHANIEGood morning.

10:40:19

REHMGo right ahead, please.

10:40:21

STEPHANIEHi. My mother had a spinal epidural in fall of 2011. So this was a year ago that's, you know, first came up in the news. And about 20 days after that, she started showing symptoms, and we took her to her doctor and then two emergency rooms before she began being treated. And her -- so then this fall, when all of this came out, I reported this to the Ohio Department of Health, and they collected information on me as far as her doctor, and so they checked with him.

10:40:56

STEPHANIEAnd they said they would not continue studying this because of the pharmaceutical company it came from, it was not one of the compounding pharmacies. And I was just thinking that this was pretty irresponsible in light of the fact that maybe that this is bigger than we realized. And, you know, and this happened a year earlier. I don't know what other possibilities could've caused her reaction, but...

10:41:24

REHMYou're saying she came down with viral meningitis.

10:41:27

STEPHANIEYes. Yes. Then she was diagnosed with -- well, I guess they finally after eliminating other things. And that was even kind of not totally conclusive, but, you know, some doctors...

10:41:39

REHMWell.

10:41:39

STEPHANIE…that said, you know, because, I think, to be bacterial that has to grow for a certain period of time, the culture. And then I think I understood that for fungal meningitis, it needs to even grow longer than that. So after three days, she was released from the hospital.

10:41:53

REHMAll right. Lena, what have you heard?

10:41:56

SUNI don't know, but this particular steroid injection is very hard to make. And it's very hard to make it free of contaminants, you know, if it's compounded. But, Stephanie, I think you said that this was made by a drug company, right?

10:42:12

REHMShe has already hung up the phone, so I don't know. All right. Let's go to Bristol, Tenn. Steven, you're on the air.

10:42:24

STEVENHello, Diane. I love your show.

10:42:25

REHMThanks.

10:42:25

STEVENI have a question and a comment. My comment is I do not have health insurance because of the affordable -- being affordable. I'm hoping I'll be able to. But this past week, I had a doctor friend who called in two prescriptions for me for chronic untreated illness. One was a generic for $10, and I was able to pay that.

10:42:47

STEVENThe other was $174 because it does not have a generic, and I had to say no. That is just too much. I'm concerned about the price of medications here in America because of the lobbying industry that's just multi-million dollar. My question is -- to your panelists and to yourself is, when will or will the government ever get a grip on that?

10:43:16

REHMWell, you know, in this morning's program, our focus is not so much on the cost of drugs but cost does come into the issue of compounding, Lena.

10:43:32

SUNWell, I think that for a lot of end users, that most of them are hospitals and clinics and doctor's offices, compounded medications are sometimes slightly cheaper. And because they're custom-made for an individual who may have allergies, that's why they've become so popular. The issue of, you know, the cost of drugs in generics versus brand, that is -- that's a whole another area, and I'm not sure we have time to go into that this morning.

10:44:00

10:44:06

SHIRLEYHi. Yes, Diane, I love your show.

10:44:08

REHMThanks.

10:44:08

SHIRLEYI just want to -- I have a comment about this particular discussion. I'm sorry but I don't think it's terribly well-balanced, and I think the patient perspective is seriously missing here as somebody who's allergic to most prescription medications and for example, there's only like two antibiotics that I can even take.

10:44:27

SHIRLEYYou know, if -- obviously, we have to do something about the recent tragedies, but if we overload these compounding pharmacies with regulations and cost restrictions that they will simply never be able to meet such as testing every single individual batch. Then they'll simply go out of business, and people will die from that result as well.

10:44:50

REHMTo -- all right.

10:44:50

SHIRLEYSo that's my comment.

10:44:51

REHMAll right. Thanks for calling. Kasey, do you want to comment.

10:44:55

THOMPSONYeah. I couldn't agree more. It's really a balance here because there's an absolute need for compounding in patient care. There's an absolute need that there are patients who just simply cannot take a commercially available product or a commercially available product is not available. So we have to be very careful as we're looking at new federal laws and new state actions related to this issue because we don't want to leave patients out to dry here.

10:45:17

REHMOn the other hand, why should patients is left with unsafe drugs, David Miller?

10:45:24

MILLERWell, I agree, Diane. There is a balance that we have to strike here. How do we help ensure safety? First and foremost, every patient in every state needs to be protected and know that their pharmacists are being held accountable to national standards, the USP standards I mentioned earlier, and at the same time, also make sure that our boards of pharmacy are out inspecting pharmacies.

10:45:51

MILLERJust as there are problems, recalls on a regular basis the pharmacists know about with manufactured drugs, we need to, as much as possible, preserve the integrity of the drug chain supply, balancing the needs of the patients. And as your caller said, it is essential and choose a good example of the kind of individuals that compounding pharmacies take care of as opposed to manufacturers who make and sell drugs. So we have to be very, very aware of the importance, and place the patient first and foremost...

10:46:26

REHMBut, David, let me ask you specifically. Since the outbreak and since the deaths, what kinds of changes has the compounding pharmacy industry made to insure that the drugs you are creating are safe?

10:46:51

MILLERWell, again, really our organization has two big focuses as we move forward on the state level. The first is the implementation, mandatory following of the professional standards that are developed at the national level, the USP standards. The second is making sure that our Boards of Pharmacy are adequately funded with trained inspectors to be doing regularly, unannounced inspections of all pharmacies and compounding pharmacies in particular.

10:47:20

MILLERThat's how we ensure safety. That's exactly what the FDA does with manufacturers is setting and holding people to standards and then requiring regular inspections to ensure those standards are being carried by the board.

10:47:32

REHMAll right. Lena, is that enough?

10:47:36

SUNWell, I think that for the industry to say that the state boards need to go out there and do unannounced surprise inspections is all well and good, state boards don't have that kind of money. Are you saying that the pharmaceutical industry is going to foot the bill for them to do that?

10:47:52

MILLERWell, I think that's sort of disingenuous. One of the things when you examine the budgets of state Boards of Pharmacy is that we realize over the past five to 10 years, those boards which are traditionally self-funding through fees and permits that they collect from pharmacists and pharmacies have seen their budgets cut and have their moneys siphoned away from doing their business -- inspections, et cetera -- and having that money captured into state funds for general use -- roads, education, et cetera.

10:48:26

MILLERI don't think it's a question that we don't have the money. The money is actually there. It's making sure that our legislators allocate that money back to the boards so that they are adequately funded to do what they're charged to do.

10:48:39

REHMLena.

10:48:40

SUNYes, but every state has different boards and different laws, so you have a complete patchwork. I remember when we were doing our reporting about the PharMEDium plant in Cleveland, Miss., that twice mislabeled pain medication so that a patient got morphine instead of getting Fentanyl citrate. This happened twice, and it was human error. The Mississippi Board of Pharmacy had inspected that plant at least nine times. Each time they inspected, they found that the ratio of pharmacists who are supposed to oversee technicians was woefully low. Nothing ever happened.

10:49:20

MILLERWell, Lena, at the same time, I can cite a number of examples from the manufactured side. In fact, the same week that the NACC tragedy broke Hospira, which is an FDA-regulated manufacturer with recalled IV bags contaminated with fungus, just last -- two weeks ago, the same company did the same thing. There's always -- and it pains me as a pharmacist to say this. There's always going to be errors in our system, whether it's a compound, a drug or a manufactured drug.

10:49:56

10:50:08

CATIZONEWhat was the last part, Diane, equally?

10:50:10

REHMIs it equally risky for us as patients to know that the pharmaceuticals we are receiving have been thoroughly inspected, have been thoroughly regulated? Is there any difference between the compounders and the manufacturers?

10:50:34

CATIZONEYes, it's not equally risky. And what happened toward this issue is we confuse what the primary discussion should be. Compounding pharmacies, compounding -- there should be no major legislative changes there. The pharmacy should be made to adhere to the USP standards, as David said, to the patient's call. If I as a pharmacy and pharmacist can't comply with those standards, I shouldn't be preparing those medications.

10:50:56

CATIZONEWe don't allow people to prepare and sterilize food unless they can meet standards to make sure those products are safe. We should impose the same type of thinking with the drug products. The area we're concerned about is this area where these companies are functioning as manufacturers under the guise of a pharmacy. We need regulation there. It needs to be federal.

10:51:15

CATIZONEIt needs to be the FDA addressing them as manufacturers, and the states can support that. But this is the area that we're talking about, and this is where the regulation lacks. Compounding pharmacies are doing a good job when they file those standards, and the state boards need more resources to ensure it. But the area we're talking about has been unregulated and that needs to change.

10:51:34

REHMAnd, Lena, you talked earlier about the Congress. What are you seeing in the way of follow up?

10:51:42

SUNI think there have been -- there were two bills that are introduced in the last Congress, and they, of course, have to be reintroduced in the new Congress. And I believe Rep. Ed Markey from Massachusetts -- the NECC is in his district -- has said he would introduce updated legislation. And on the Senate side...

10:52:01

REHMAnd what would that legislation do?

10:52:04

SUNIt would allow to give FDA more authority over this group of so-called high-risk compounders...

10:52:10

REHMAll right.

10:52:11

SUN...and require them to report adverse events, you know, more transparency. On the Senate side, after Sen. Tom Harkin had a hearing last November, the end of the hearing, he expressed his willingness to see bipartisan legislation get introduced at some point in the Congress this year.

10:52:29

REHMAnd do you believe that could really happen.

10:52:34

SUNI hope so.

10:52:36

10:52:45

SUEGood morning, Diane. I have a comment and a question. My comment is I think we need more regulation. I think the bottom line for most pharmacies is money. They wouldn't -- they don't produce the cancer medicine that people need, and I think the government should have something to say about that. They always cry, oh, they need their money for research.

10:53:14

SUEBut I take -- I have three eye drops that I take because I have glaucoma. And my sight depends on that because I also have macular degeneration. And I had found that the generic eye drops I get come from all over the world. And the way I know that is I read everything on the bottles and the boxes, and I've seen Cyrillic writing. And I can tell often what country they come from...

10:53:50

REHMAll right.

10:53:50

SUE...mostly the generic. And they -- and I think when...

10:53:54

REHMAnd your question, Sue?

10:53:58

SUEDo -- the pharmacist just told me that the FDA regulates those when they come in to the country?

10:54:09

REHMIs that true, Kasey?

10:54:10

THOMPSONThat is true. Unless somebody is buying something over the Internet or buying at, you know, across Canada or Mexico, then they shouldn't...

10:54:17

REHMShe said from around the world.

10:54:19

THOMPSONYeah. Well, there are manufacturing plants around the world, so that could very well be the case. A wide raw of chemicals are brought in from around the world. Manufacture happens -- manufacturing happens in other country. The key is, is it FDA approved? And that should be easily discoverable by the patient by talking to their pharmacist and making absolutely sure they're getting a FDA-approved product. If it's sold in a pharmacy in the United States, it should be FDA approved.

10:54:40

REHMSo how does one then get these drugs that come from compounding pharmacies?

10:54:50

THOMPSONWell, they would get it based on a prescription from the physician, and it would be filled in the outpatient set in by a compounding pharmacist or a community pharmacy that does compounding.

10:55:01

REHMAnd I can be sure if it's coming through my doctor and my pharmacy, for example, CVS, that that has been inspected and is absolutely what it claims to be?

10:55:24

THOMPSONYou would hope that's the case.

10:55:25

REHMA hope?

10:55:25

THOMPSONI mean, my hope would be that, you know, pharmacies are using FDA-approved products for compounding. That's a real key.

10:55:32

REHMLena.

10:55:33

SUNI always ask now.

10:55:34

REHMWhat do you asks?

10:55:36

SUNWhere did, you know, if I ask for a prescription, I call the pharmacist and say, you know, how was this made? Did you get this from a drug manufacturer or has this been compounded?

10:55:47

REHMDavid Miller, do you think more and more people are going in that direction?

10:55:52

MILLERDiane, I certainly hope so. Our organization is pushing and, in fact, recommends that any compounded prescription be labeled as such so it's clear to the patient. But the most important thing that anyone can do who receives any prescription medication, compounded or otherwise, is ask their pharmacist and ask their physician questions. It is important that patients are just as engaged in their therapy as decision makers as the clinicians that are taking care of them.

10:56:23

REHMAll right. But, Carmen Catizone, it also sounds as though you're saying to individuals, ask your member of Congress to make sure that these drugs get more careful regulation.

10:56:40

CATIZONEYes, both at the state and federal level.

10:56:44

REHMAll right. We'll have to leave it there. Carmen Catizone of the Association of Boards of Pharmacy, Lena Sun, a reporter for The Washington Post, Kasey Thompson of the American Society of Health-System Pharmacists and David Miller. He is executive vice president and CEO of the International Academy of Compounding Pharmacists. Thank you all so much.

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